Aseptic Meningoencephalitis in Slovenia
- Conditions
- Aseptic Meningitis
- Interventions
- Registration Number
- NCT02328469
- Lead Sponsor
- University Medical Centre Ljubljana
- Brief Summary
The main objective of this study is:
* to establish etiology of acute aseptic meningitis/meningoencephalitis in Slovenia
* to assess the clinical course and outcome of tick-borne encephalitis and Lyme neuroborreliosis
* to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with tick-borne encephalitis and Lyme neuroborreliosis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
- clinical picture compatible with aseptic meningitis/meningoencephalitis
- age 18 years or older
- clear cerebrospinal fluid on macroscopic examination
- cerebrospinal pleocytosis (> 5 x 106 white blood cells per liter)
- younger than 18 years
- pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lyme neuroborreliosis Ceftriaxone or Doxycycline Patients with acute aseptic meningitis in whom Lyme neuroborreliosis will be proven or suspected according to microbiological criteria. Patients will be treated with antibiotic therapy (ceftriaxone or doxycycline) and will be asked to complete a questionnaire. unidentified aseptic meningitis questionnaire Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire. unidentified aseptic meningitis symptomatic therapy Patients with etiologically unidentified aseptic meningitis will be treated with symptomatic therapy and will be asked to complete a questionnaire. tick-borne encephalitis questionnaire Patient with aseptic meningitis in whom serological diagnosis of tick-borne encephalitis will be established. Patients will be treated with symptomatic therapy and will be asked to complete a questionnaire. Lyme neuroborreliosis symptomatic therapy Patients with acute aseptic meningitis in whom Lyme neuroborreliosis will be proven or suspected according to microbiological criteria. Patients will be treated with antibiotic therapy (ceftriaxone or doxycycline) and will be asked to complete a questionnaire. healthy controls symptomatic therapy Patients will be asked to refer a spouse to serve as a control . If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control. tick-borne encephalitis symptomatic therapy Patient with aseptic meningitis in whom serological diagnosis of tick-borne encephalitis will be established. Patients will be treated with symptomatic therapy and will be asked to complete a questionnaire. Lyme neuroborreliosis questionnaire Patients with acute aseptic meningitis in whom Lyme neuroborreliosis will be proven or suspected according to microbiological criteria. Patients will be treated with antibiotic therapy (ceftriaxone or doxycycline) and will be asked to complete a questionnaire. healthy controls questionnaire Patients will be asked to refer a spouse to serve as a control . If unmarried they will be asked to refer a family member or a friend of +/- 5 years to serve as a control. identified aseptic meningitis symptomatic therapy Patients with microbiologically identified cause of acute aseptic meningitis/meningoencephalitis will receive symptomatic therapy. If the identified causative agent will be Herpes Simplex Virus or Varicella Zoster Virus, patients will be treated with acyclovir and will be asked to complete a questionnaire. identified aseptic meningitis Acyclovir Patients with microbiologically identified cause of acute aseptic meningitis/meningoencephalitis will receive symptomatic therapy. If the identified causative agent will be Herpes Simplex Virus or Varicella Zoster Virus, patients will be treated with acyclovir and will be asked to complete a questionnaire. identified aseptic meningitis questionnaire Patients with microbiologically identified cause of acute aseptic meningitis/meningoencephalitis will receive symptomatic therapy. If the identified causative agent will be Herpes Simplex Virus or Varicella Zoster Virus, patients will be treated with acyclovir and will be asked to complete a questionnaire.
- Primary Outcome Measures
Name Time Method Changes in selected clinical parameters in patients with acute aseptic meningitis/meningoencephalitis at enrollment and during 12 months follow-up Selected clinical parameters (presence or absence of headache, nausea, vomiting, neurologic symptoms, maximal temperature, etc) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and at follow-up visits: on day 7 or on day of discharge from hospital, on day 14, at 2, 6, and 12 months.
Changes in selected microbiologic parameters in patients with acute aseptic meningitis/meningoencephalitis at enrollment and during 12 months follow-up Selected microbiologic parameters (anti Borrelia burgdorferi immunoglobulin M and G in serum and cerebrospinal fluid results, polymerase chain reaction for enteroviruses, herpes simplex virus type 1 and 2 in cerebrospinal fluid results) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and anti Borrelia burgdorferi immunoglobulin M and G in serum at follow-up visits: at 2, 6, and 12 months.
Changes in selected laboratory parameters in patients with acute aseptic meningitis/meningoencephalitis at enrollment and during 12 months follow-up Selected laboratory parameters (complete blood count, biochemistry test results) in aseptic meningitis/meningoencephalitis patients at enrollment (at admission to hospital) and at follow-up visits: on day 7 or on day of discharge from hospital, on day 14, at 2, 6, and 12 months.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
UMC Ljubljana, Department of Infectious Diseases
🇸🇮Ljubljana, Slovenia
Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia
🇸🇮Ljubljana, Slovenia